To establish an IRB review fee policy and billing process for research proposals that are submitted to and reviewed by the Cottage Health System Institutional Review Board for approval.

POLICY:

A $1,500 IRB review fee is required of all commercially sponsored research studies. A fee waiver will be applied in emergency use protocols (for life-threatening situations – limited to two patient approvals per year per investigator). If the study undergoes continuing review, there will be a $500 IRB review fee for sponsored studies. Currently, there is no fee for unsponsored or independent, or research conducted by employees or residents who are participating in such research.

DEFINITIONS:

Sponsored Research: Research activities that are supported and funded by a commercial vendor (i.e., Pharmaceutical Company, Investigational Device Vendor).

Independent/Non-sponsored Research: Research activities that are not commercially funded, i.e., independent research and federally-funded research (including studies supported by grants from NIH or any funding branch of DHHS).

Waiver of IRB Fee: Some situations are eligible for an IRB fee waiver (see Section G). This list is not all-inclusive and other situations may be approved on a case-by-case basis.

PROCEDURE :

Research studies will be billed by the institution to the study sponsor directly.

If, in the course of the review of the research application, it is determined that the study needs to be reassigned from one fee category to another (an un-sponsored study has been determined to be a sponsored study) or if it is determined that the study is not eligible for billing, the investigator will be notified.

Fees for sponsored studies will be required for IRB review of new studies and continuing review of active studies. Currently, there are no additional fees charged for revised informed consents, amendments or revisions to the protocol, adverse event reports, or advertisements. The original fee and continuing review fee are designed to cover the administrative costs incurred at review time, and throughout the year, for any upcoming study activities. This policy may change in the future if it is deemed necessary.

The IRB review fee covers handling, processing, and formal review of the application materials and is nonrefundable, regardless of whether or not the IRB approves activation of the study.

No additional fees will be assessed on consent revisions or other alterations, if required by the IRB for final approval of an original application.

The following fees are felt to be a minimal assessment to cover the administrative overhead costs of the Institutional Review Board:

Original review of new study:Commercially Sponsored Research: $1,500.00

IRB review of study renewal: Commercially Sponsored Research: $500.00

Circumstances under which an IRB fee waiver is appropriate:

Research conducted by Cottage employees; Cottage Residents; or students.

Local physicians requesting PHI from CHS for “preparatory to research” activities, for retrospective research, or to develop a database from Cottage PHI. This is especially true when the only IRB interaction with the physician is to approve a Waiver of Authorization or to exempt the project from further IRB review.

Research being conducted at UCSB if the investigator is a student and the study is part of their dissertation, a school project, etc. (However, if the investigator is a professor who has grant money and is doing research through his/her lab, a fee may be charged.)

TORI or CIRB studies being conducted by the Cancer Center of Santa Barbara.

Emergency use or compassionate use cases.

Devices being regulated under a Humanitarian Device Exemption (HDE; Humanitarian Use Devices).

When CHS IRB relinquishes oversight to another (outside) IRB, and the only activity is to file research related documents and acknowledge the study and its oversight by another IRB.